Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients

Chronic Hepatitis B Clinical Trial

Official title:

Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997944
• Other study ID #: 921302
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 21, 2013
• Last updated: November 14, 2014
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Beijing Bio-Fortune Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18-75 years

• Chronic HBV infection (serum HBsAg detectable for > 6 months)

• Serum HBeAg positive with HBV DNA >10^6copies/mL (or >20,000 IU/mL),orSerum HBeAg negative with HBV DNA >10^5copies/mL (or >2,000 IU/mL)

• Serum ALT must be > 2 x ULN but below 10 x ULN

Exclusion Criteria:

• Steroid treatment or immunosuppression 3 months prior to entry.

• Interferon therapy or nucleotides analogues therapy in 6 months prior to entry.

• Active lung disease or history of interstitial lung disease.

• Hb< LLN or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 ,or WBC<3000/mm3 .

• Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.

• Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).

• Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).

• History of thyroid disease or current treatment for thyroid disease.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• Human Serum ALbumin/interferon alpha2a
600,750 or 900 mcg dosing every 2 weeks
• Pegasys
180 mcg dosing every week

Locations

Country	Name	City	State
China	Jilin University First Affiliated Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Bio-Fortune Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		18 weeks	Yes
Secondary	Decrease of HBV DNA		18 weeks	No
Secondary	AUCss		18 weeks	No
Secondary	Css_av		18 weeks	No
Secondary	Css_min		18 weeks	No
Secondary	Css-max		18 weeks	No
Secondary	T1/2		18 weeks	No
Secondary	Tmax		18 weeks	No